Events

Rappel de LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-01284-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-02
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01284-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Update: beckman coulter's investigation has shown that the lh cleaner and coulter clenz was the main contributor to the optical degradation issue.Complaints related to optical degradation have increased on the lh 750 and lh 780 haematology systems. customers have reported an increase in ls offset error messages during startup, background, control and/or patient analysis.The optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.Cbc panel results are available for reporting and are not affected by this issue.
  • Action
    Update: Beckman Coulter is requesting their customers to discard the affected lot of LH Cleaner. Laboratories can discontinue the additional Clear Flow Cell and Extended Cleaning actions. Beckman Coulter is recommending users perform a Clear Flow Cell and Extended Cleaning and perform a routine shutdown at least daily. Beckman Coulter is investigating this issue further in order to provide a permanent fix.

Device

LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)LH 750 Haematology SystemPart Numbers 6605632 and A85570LH 780 Haematology System Part Numbers 723585 and A90728
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd